Laparoscopic Nissen–Rossetti Fundoplication for Gastroesophageal Reflux Disease Patients After 2-Year Follow-Up

Abstract

Introduction:

Gastroesphageal reflux disease (GERD) is a common condition in the general population, affecting patients' quality of life and predisposing to Barrett's esophagus and its most fearsome complication, esophageal adenocarcinoma. The aim of this study is to compare objective and subjective outcomes of laparoscopic Nissen–Rossetti fundoplication after 2 years of follow-up.

Subjects and Methods:

Seventy-six GERD patients underwent laparoscopic Nissen–Rossetti fundoplication. Patients were subjected to close follow-up.

Results:

The DeMeester and Johnson score average decreased from a mean preoperative value of 35.48 (SD±40.24) to 9.83 (SD±6.40) at 6 months; at 12 months it was 11.44 (SD±10.28), and at 24 months it was 10.25 (SD±5.61). GERD Health-Related Quality of Life decreased from a preoperative value of 23.04 (SD±11.59) to 9.84 (SD±8.98) at 6 months, 8.34 (SD±8.98) at 12 months, and 6.8 (SD±6.46) at 24 months. The Short Form-36 measurement showed significant improvement.

Conclusions:

GERD patients need adequate reflux control. Successful antireflux surgery is more effective than medical therapy in preventing both acid and bile reflux. Surgical therapy is effective in terms of reflux control and improvement in quality of life. Strict and rigorous follow-up with both subjective and objective tests is important in order to identify asymptomatic recurrence of reflux after surgery.

Introduction

Gastroesophageal reflux disease (GERD) represents one of the most widespread diseases affecting the alimentary tract. The recent improvements in epidemiological studies and the rising awareness among general practitioners of this disease, as well as an increased use of innovative tools, have allowed a more precise identification of symptoms related to reflux disease. The surgical treatment in these patients has always been confined to complicated GERD or in those cases with severe symptoms unresponsive to drug therapy with proton pump inhibitors (PPI). Today, there is a growing tendency to use surgical treatment even in the early stages,¹ due mainly to improvements in surgical techniques related to minimally invasive surgery, which is well accepted by patients, and the impact on quality of life in GERD patients who are not properly treated. Surgical treatment aims to gain complete control of symptoms, to improve quality of life, and to stop esophageal mucosal damage in the development of Barrett's esophagus and its most fearsome complication, esophageal adenocarcinoma. One of the issues of concern is the choice of the best treatment to be taken. Surgical treatment is to be preferred to medical treatment with PPI taken long term; short- and long-term studies show, in fact, that antireflux surgery is effective in eliminating symptoms in 88–95% of cases with excellent satisfaction.^2,3 In a previous work carried out in our referral center between January 2006 and July 2007, we showed that Nissen–Rossetti fundoplication is a safe, efficient surgical procedure with good results in the short term.⁴ Furthermore, the Nissen–Rossetti procedure, performed by experienced surgeons, can be short and floppy with minimization of side effects, as shown in our previous study.⁵ The aim of this study is to evaluate clinical and functional results after 2 years of follow-up in GERD patients who underwent Nissen–Rossetti laparoscopic fundoplication.

Subjects and Methods

Instrumental and clinical evaluation

Between January 2007 and September 2010, 76 patients underwent laparoscopic Nissen–Rossetti fundoplication. All patients were evaluated through an accurate anamnesis to investigate general health status, predominant symptoms, and use of antiacids or PPI. Endoscopy was performed by using an Olympus GIF Q20 fiberscope to assess if hiatal hernia and/or hypotonic sphincter was present and to evaluate the conditions of esophageal mucosa; if necessary, biopsy specimens were taken. All biopsy specimens were analyzed by the same expert pathologist. Esophagitis, if present, was classified into four grades (A–D) according to the Los Angeles classification.

When drug therapy was poorly effective in controlling symptoms or there was recurrence of symptoms in the case of suspension or in the case of poor patient compliance a 24-hour measurement of pH was performed using the Flexilog 2000 dual channel ambulatory pH monitor. The parameters considered were the DeMeester and Johnson score (cutoff, 14.72), the total number of reflux episodes (cutoff, 46.9), the number of episodes longer than 5 minutes, and the percentage of total acid exposure (cutoff, 4.5%), upright and supine.

A preoperative radiographic control was obtained for patients with voluminous hiatal hernia (>4–5 cm).

No esophageal manometry was performed on any patient.

In agreement with the guidelines of the Society of American Gastrointestinal and Endoscopic Surgeons⁶ for the diagnosis and treatment of GERD, all patients with GERD diagnosed clinically and instrumentally were subjected to further courses of medical therapy with PPI and dietary and lifestyle changes before considering surgery. The criteria used for the indications for surgery were as follows:

• GERD not responsive or not completely controlled by medical therapy with PPI

• Barrett's esophagus diagnosed histologically

• Impossibility to continue therapy for a lifetime

• GERD-related complications (Schatzki ring, esophageal stricture, etc.)

Quality of life was evaluated using the Short Form-36 (SF-36) and GERD Health-Related Quality of Life (GERD-HRQL).

The SF-36 is an instrument consisting of 36 questions with multiple answers referring to eight dimensions: Physical functioning, role physical, bodily pain, general health perception, vitality, social functioning, role emotional, and mental health. For each dimension, scales are scored according to a Likert method, obtaining a value for each dimension that may range from 0 (worst health status for that dimension) and 100 (best health status).

The GERD-HRQL is a nine-item, Likert-type questionnaire that measures the severity of heartburn, heartburn lying down, heartburn standing up, heartburn after meals, change of diet, nocturnal heartburn, dysphagia, odynophagia, and effects of medications. The GERD-HRQL score is derived from adding the scores from each of the nine items. The best possible score is 0 (i.e., asymptomatic in each item), and the worst possible score is 45 (incapacitated in each item).

Both the SF-36 and the GERD-HRQL quality-of-life instruments were completed by the patients under observation of a physician.

Surgical procedure

Laparoscopic Nissen–Rossetti funduplication was performed in all patients. All surgical procedures were performed by the same surgeon (F.T.). The patient's position was a 30° reverse-Trendelenburg, and the surgeon was placed between the patient's leg, while the camera operator was on the left side, and the assistant was on the right side. Five 10-mm trocars were used. The first trocar was placed in the midline about 12 cm under the xiphoid, with the second and the third placed in the left and right midclavicular lines. The short gastric vessels were not routinely divided because this was not felt to be necessary in order to obtain a wide retroesophageal window and an easy passage of the posterior gastric wrap. A floppy funduplication was performed in all patients around an endoesophageal 48-Fr bougie. The wrap was fixed with two or three nonabsorbable sutures, which did not include the esophageal anterior wall. A gastrogastric stitch was made (Rossetti technique) to stabilize the position of the anterior wrap. The esophageal hiatus was closed with one or two interrupted sutures without using mesh, when necessary.

Postoperative follow-up

All patients underwent a close follow up, according to the following schedule:

• 1 month: radiological study

• 6, 12, and 24 months: clinical examination, endoscopy, pH-metry, SF-36, and GERD-HRQL

Statistical analysis

In order to test any differences between the pH-metry and the questionnaire variables measured in the preoperative period versus at 6, 12, and 24 months, the paired t test was used when data were normally distributed. The Shapiro–Wilk test was used to verify the normality of the data. When data were not normally distributed, transformation was required. We used logarithmic or quadratic transformation when data were positively (right) skewed. When data were not normally distributed after the transformation, we used the nonparametric Wilcoxon test. Statistical analysis was performed using SAS (Statistical Analysis System) version 9.2.

Results

Seventy-six patients (24 males, 52 females; median age, 43 years [range, 20–71 years]) underwent laparoscopic Nissen–Rossetti fundoplication between January 2007 and September 2010.

Preoperative assessment

Forty-eight (63.16%) patients had typical symptoms before surgery, 22 (28.95%) patients had both typical and atypical symptoms, and only 6 patients (7.89%) complained of extraesophageal symptoms. All patients were subjected to preoperative endoscopy. Forty-five patients (59.21%) had a sliding hiatal hernia between 2 and 3 cm, 4 (5.26%) patients had a voluminous hiatal hernia (>3 cm), and mixed hiatal hernia was noted in 4 cases (5.26%); 23 patients had lower esophageal sphincter primitive endoscopy incontinence (30.27%).

All patients underwent 24-hour pH-metry before surgery. The DeMeester and Johnson score average was 35.48 (SD±40.24), total number of refluxes was 41.37 (SD±20.15), longest episode average was 55.44 minutes (SD±60.53), total percentage having pH <4 was 14.04 (SD±19.52), supine percentage having pH <4 average was 15.74 (SD±25.13), and erect percentage having pH <4 average was 10.54 (SD±14.70) (Table 1).

Table 1.

The 24-Hour pH-Metry Parameters, Gastroesophageal Reflux Disease Health-Related Quality of Life, and Short Form-36 Average Values Preoperatively and at 6 Months

	Mean±SD
	Before surgery	6 months	P value
24-hour pH-metry
D&J score	35.48±40.24	9.83±5.86	<.0001
Total reflux (no. of episodes)	41.37±20.15	16.38±18.68	<.0001
>5 minutes	55.44±60.53	14.68±21.11	<.0001
Total % pH <4	14.04±19.52	2.33±2.80	<.0001
Supine (%)	15.74±25.13	1.81±2.84	<.0001
Erect (%)	10.54±14.70	2.72±3.49	<.0001
SF-36
Physical functioning	69.25±32.59	71.96±32.92	.0009
Role physical	46.05±40.32	66.41±44.01	<.0001
Bodily pain	37.93±26.74	56.75±32.02	<.0001
General health	43.13±22.98	52.00±25.57	.0006
Vitality	49.44±22.95	55.53±25.71	.0058
Social functioning	47.74±25.16	63.66±29.85	<.0001
Role emotional	49.22±37.04	63.55±40.97	<.0001
Mental health	54.23±23.10	62.60±21.95	.0004
GERD-HRQL	23.04±11.59	9.84±8.98	.0401

Statistical analysis showed significant differences for P value<.05.

D&J, DeMeester and Johnson; GERD-HRQL, Gastroesophageal Reflux Disease Health-Related Quality of Life; SD, standard deviation, SF-36, Short Form-36.

Perioperative outcomes

All patients underwent successfully laparoscopic Nissen–Rossetti fundoplication. In 8 patients cholecystectomy was associated, because of symptomatic cholelithiasis. No conversion to an open transabdominal approach was required. No intraoperative complications (pleural tears, esophageal/gastric perforation, splenic/liver injury) occurred. No death occurred during the intervention. In 42 patients use of plastic diaphragm pillars without mesh was needed. Median operative time was 75 minutes (range, 30–240 minutes). Median hospital stay was 3 days (range, 2–15 days).

24-hour pH-metry postoperative assessment

All patients of this study had postoperative pH monitoring at 6, 12, and 24 months. The DeMeester and Johnson score average decreased from 35.48 (SD±40.24) preoperatively to 9.83 (SD±6.40) at 6 months. At 12 months it was 11.44 (SD±10.28), and at 24 months it was 10.25 (SD±5.61). Preoperative and postoperative 24-hour pH-metry parameters are shown in Tables 1 –6. Statistical analysis showed significant differences when comparing preoperative values with those obtained in the subsequent follow-up checks (Tables 1 –3) and in the comparison between 6 versus 12 months and 6 versus 24 months (Tables 4 and 5), whereas there were no significant differences in the comparison between 12 and 24 months (Table 6). The other parameters considered decreased in the subsequent follow-up checks, and statistical analysis showed significant differences when comparing preoperative values with those recorded at 6, 12, and 24 months, whereas no statistically significant differences were found in the comparison between postoperative values (Tables 4 –6).

Table 2.

The 24-Hour pH-Metry Parameters, Gastroesophageal Reflux Disease Health-Related Quality of Life, and Short Form-36 Average Values Preoperatively and at 12 Months

	Mean±SD
	Before surgery	12 months	P value
24 h pH-metry
D&J score	35.48±40.24	11.44±10.28	<.0001
Total reflux (no. of episodes)	41.37±20.15	16.91±22.89	<.0001
>5 minutes	55.44±60.53	11.45±19.79	<.0001
Total % pH <4	14.04±19.52	2.67±5.05	<.0001
Supine (%)	15.74±25.13	1.98±4.09	<.0001
Erect (%)	10.54±14.70	2.92±5.71	<.0001
SF-36
Physical functioning	69.25±32.59	73.59±31.96	.0015
Role physical	46.05±40.32	72.39±40.44	<.0001
Bodily pain	37.93±26.74	64.50±31.47	<.0001
General health	43.13±22.98	56.57±27.03	.0006
Vitality	49.44±22.95	63.33±25.23	<.0001
Social functioning	47.74±25.16	69.78±28.23	<.0001
Role emotional	49.22±37.04	71.76±38.15	<.0001
Mental health	54.23±23.10	66.65±22.14	<.0001
GERD-HRQL	23.04±11.59	8.34±8.98	<.0001

Statistical analysis showed significant differences for P value<.05.

Table 3.

The 24-Hour pH-Metry Parameters, Gastroesophageal Reflux Disease Health-Related Quality of Life, and Short Form-36 Average Values Preoperatively and at 24 Months

	Mean±SD
	Before surgery	24 months	P value
24 h pH-metry
D&J score	35.48±40.24	10.25±5.61	.0034
Total reflux (no. of episodes)	41.37±20.15	8.75±14.64	.0009
>5 minutes	55.44±60.53	14.89±25.16	.0061
Total % pH <4	14.04±19.52	2.12±3.04	.0003
Supine (%)	15.74±25.13	1.11±2.53	.0006
Erect (%)	10.54±14.70	2.54±3.38	.0027
SF-36
Physical functioning	69.25±32.59	79.9±25.55	.0004
Role physical	46.05±40.32	72.53±37.90	.0006
Bodily pain	37.93±26.74	71.21±28.23	<.0001
General health	43.13±22.98	64.15±21.64	.0004
Vitality	49.44±22.95	60.15±23.36	<.0001
Social functioning	47.74±25.16	78.65±27.59	<.0001
Role emotional	49.22±37.04	80.00±32.86	.0002
Mental health	54.23±23.10	67.22±22.23	.0001
GERD-HRQL	23.04±11.59	6.8±6.46	.0010

Statistical analysis showed significant differences for P value<.05.

Table 4.

The 24-Hour pH-Metry Parameters, Gastroesophageal Reflux Disease Health-Related Quality of Life, and Short Form-36 Average Values at 6 and 12 Months

	Mean±SD
	6 months	12 months	P value
24 h pH-metry
D&J score	9.83±5.86	11.44±10.28	<.0001
Total reflux (no. of episodes)	16.38±18.68	16.91±22.89	NS
>5 minutes	14.68±21.11	11.45±19.79	NS
Total % pH <4	2.33±2.80	2.67±5.05	NS
Supine (%)	1.81±2.84	1.98±4.09	NS
Erect (%)	2.72±3.49	2.92±5.71	NS
SF-36
Physical functioning	71.96±32.92	73.59±31.96	NS
Role physical	66.41±44.01	72.39±40.44	NS
Bodily pain	56.75±32.02	64.50±31.47	.0001
General health	52.00±25.57	56.57±27.03	NS
Vitality	55.53±25.71	63.33±25.23	.0014
Social functioning	63.66±29.85	69.78±28.23	.0001
Role emotional	63.55±40.97	71.76±38.15	NS
Mental health	62.60±21.95	66.65±22.14	.0061
GERD-HRQL	9.84±8.98	8.34±8.98	<.0001

Statistical analysis showed significant differences for P value<.05.

NS, not significant (P value>.05).

Table 5.

The 24-Hour pH-Metry Parameters, Gastroesophageal Reflux Disease Health-Related Quality of Life, and Short Form-36 Average Values at 6 and 24 Months

	Mean±SD
	6 months	24 months	P value
24 h pH-Metry
D&J score	9.83±5.86	10.25±5.61	<.0001
Total reflux (no. of episodes)	16.38±18.68	8.75±14.64	NS
>5 minutes	14.68±21.11	14.89±25.16	NS
Total % pH<4	2.33±2.80	2.12±3.04	NS
Supine (%)	1.81±2.84	1.11±2.53	NS
Erect (%)	2.72±3.49	2.54±3.38	NS
SF-36
Physical functioning	71.96±32.92	79.9±25.55	NS
Role physical	66.41±44.01	72.53±37.90	NS
Bodily pain	56.75±32.02	71.21±28.23	.0035
General health	52.00±25.57	64.15±21.64	NS
Vitality	55.53±25.71	60.15±23.36	NS.
Social functioning	63.66±29.85	78.65±27.59	.0064
Role emotional	63.55±40.97	80.00±32.86	NS
Mental health	62.60±21.95	67.22±22.23	NS
GERD-HRQL	9.84±8.98	6.8±6.46	NS

Statistical analysis showed significant differences for P value<.05.

NS, not significant (P value>.05).

Table 6.

The 24-Hour pH-Metry Parameters, Gastroesophageal Reflux Disease Health-Related Quality of Life, and Short Form-36 Average Values at 12 and 24 Months

	Mean±SD
	12 months	24 months	P value
24-hour pH-metry
D&J score	11.44±10.28	10.25±5.61	NS
Total reflux (no. of episodes)	16.91±22.89	8.75±14.64	NS
>5 minutes	11.45±19.79	14.89±25.16	NS
Total % pH<4	2.67±5.05	2.12±3.04	NS
Supine (%)	1.98±4.09	1.11±2.53	NS
Erect (%)	2.92±5.71	2.54±3.38	NS
SF-36
Physical functioning	73.59±31.96	79.9±25.55	NS
Role physical	72.39±40.44	72.53±37.90	NS
Bodily pain	64.50±31.47	71.21±28.23	NS
General health	56.57±27.03	64.15±21.64	NS
Vitality	63.33±25.23	60.15±23.36	NS
Social functioning	69.78±28.23	78.65±27.59	NS
Role emotional	71.76±38.15	80.00±32.86	NS
Mental health	66.65±22.14	67.22±22.23	NS
GERD-HRQL	8.34±8.98	6.8±6.46	.0210

Statistical analysis showed significant differences for P value<.05.

NS, not significant (P value>.05).

Quality of life postoperative assessment

Preoperative GERD-HRQL average was 23.04 (SD±11.59); it decreased to 9.84 (SD±8.98) at 6 months, to 8.34 (SD±8.98) at 12 months, and 6.8 (SD±6.46) at 24 months. Statistical analysis showed significant differences when comparing preoperative values with those recorded at 6, 12, and 24 months (Tables 1 –3), in the comparison between 6 and 12 months (Table 4), and between 12 and 24 months (Table 6), but no significant differences were found between 6 and 12 months (Table 5). SF-36 measurement showed significant improvement in all subdomains at 6, 12, and 24 months. Statistical analysis showed significant differences when comparing preoperative values with those obtained at 6 (Table 1), 12 (Table 2), and 24 (Table 3) months; furthermore, we found statistically significant differences in the comparison between 6 versus 12 (Table 4) and 24 (Table 5) months, whereas no differences were found between 12 versus 24 months (Table 6).

Overall postoperative aspects

One patient developed severe dysphagia 3 days after surgery. Endoscopy showed an abnormal narrowing of the distal esophagus. A barium swallow examination confirmed the presence of esophageal clearance failure. Laparoscopic reoperation was required 7 days afterwards: “Defunduplication” was performed, and a new Nissen–Rossetti fundoplication was creating using an endoesophageal bougie. Nine of 76 patients (11.1%) reported dysphagia for solids for at least 3 months, and 5 required recovery and pneumatic dilatation; in 1 case, after unsuccessful pneumatic dilatation, reoperation was required. In this case the patient claimed severe dysphagia 4 months after surgery and was subjected to endoscopy, which revealed a stenosis of distal esophagus, and a barium swallow examination confirmed the reduction of esophageal clearance. Thus, laparoscopic reintervention consisted in the removal of fibrotic tissue and the suture between diaphragmatic pillars; the anterior wall of the valve was sectioned with a stapler, and a Toupet fundoplication was performed. No dysphagia was reported at 6 and 12 months. After 24 months we observed 1 case of symptomatic slipped Nissen; endoscopy follow-up, pH-metric evaluation, and barium swallow were positive for recurrent GERD, and reoperation was required. Data relating to follow-up examination carried out by patients who underwent reoperation were excluded from this study.

No gas-bloat syndrome was reported during follow-up.

Discussion

GERD is a common condition in the general population. Dent et al.⁷ in a recent work have shown that this chronic condition affects 15–20% of the Western population and 5% of the Asian population.

Nowadays the discussion concerns the choice of the best treatment for GERD patients. Surgical treatment seems to be more effective than long-term drug therapy with PPIs; this is confirmed by a randomized study conducted from 1997 to 2001 by Mahon et al.,⁸ which showed that patients undergoing laparoscopic Nissen fundoplication have better results in terms of reflux control and quality of life when compared with drug therapy. Lundell et al.⁹ in another randomized study confirmed these results after 5-year follow-up, and Spechler et al.¹ showed after 10-year follow-up that antireflux surgery is more effective in obtaining a long-lasting resolution of symptoms than patients receiving PPI treatment.

The guidelines of the American Society of Gastrointestinal Endoscopic Surgeons argue that surgery is curative in 85–93% of cases and suggest that this procedure is appropriate in those cases in which medical therapy has failed or in those patients who prefer surgery despite successful therapy with PPI, for patients who develop GERD complication, or in the case of atypical symptoms and pH-metric-proven pathological refluxes.⁶

Since 1991, when Dallemagne et al.¹⁰ performed the first laparoscopic Nissen fundoplication, this technique has been preferred to open procedures because of its lower morbidity and mortality, shorter hospital stay, faster recovery, and less postoperative pain.

In a review by Catarci et al.,¹¹ laparoscopic fundoplication was found to be as effective as its open counterpart in early functional results and outcome.

Salminem et al.¹² in a recent randomized controlled trial with an 11-year follow-up compared the laparoscopic approach with conventional Nissen fundoplication and concluded that both laparoscopic and open approaches for Nissen fundoplication have a similar long-term subjective symptomatic outcome, despite the significantly greater evidence of incisional hernia and defective fundic wraps at endoscopy in the open group.

Furthermore, in a recent meta analysis, Peters et al.¹³ compared laparoscopic antireflux surgery (n=503) and open antireflux surgery (n=533). The investigators concluded that the laparoscopic approach enables a faster convalescence and return to productive activities, with a reduced risk of complications and a similar treatment outcome when compared with the open technique.

The large success of laparoscopic surgery as an effective treatment of GERD has established minimal invasive surgery as the gold standard in the surgical treatment of this condition. Among antireflux procedures, laparoscopic total fundoplication is the most commonly used, providing excellent reflux control^14–17 and symptom relief.¹⁸

However, the aim of the surgical treatment is not only the improvement of patients' quality of life, but also the creation of an effective barrier against acid and bile reflux, which is essential to prevent the progression of the damage to the esophageal mucosa and to promote the regression.

Several diagnostic instruments can be used in the preoperative period and later in the follow-up: Subjective data can be collected through the use of questionnaires investigating symptoms, the level of satisfaction with the operation, and effects on quality of life and health status, whereas objective data can be obtained through endoscopy, which assesses the severity of inflammation of the esophageal mucosa, the presence of hiatal hernia, or failure of surgery, and through 24 hour pH-monitoring, which evaluates the presence of pathological reflux in the preoperative period or the recurrence, even asymptomatic, of disease in the postoperative period.

Most of the studies currently available use subjective tests; objective evaluations are more difficult to obtain, both because they are more invasive and because they are not well tolerated by patients.

A study by Zeman and Tihanyi¹⁹ has considered the data obtained after administration of a questionnaire on quality of life (QOLARS) in 41 patients undergoing laparoscopic antireflux surgery in the preoperative period and at 6 weeks and 12 and 36 months after surgery. At 6 weeks, all the scores derived from different domains improved with the exception of dysphagia, which worsened, while after 12 months those items related to physical activity, social sphere, appetite, pain, need for drugs, overall quality of life, nausea and vomiting, heartburn, and satisfaction improved. At 3 years the results have remained stable compared with the previous control. The authors concluded that antireflux surgery improves quality of life and eliminates the need for medication in most patients; in addition, questionnaires on quality of life turn out to be a sensitive tool to define the outcome of antireflux surgery.¹⁹

Another study carried out by Amato et al.²⁰ evaluated 102 patients undergoing laparoscopic antireflux surgery in a 5-year follow-up during which the effectiveness of surgical treatment was studied with questionnaires on symptoms (heartburn, epigastralgia, dysphagia, regurgitation, respiratory symptoms, and swelling) and a questionnaire on perceived health status (SF-36). All the subdomains improved after surgical treatment with the exception of dysphagia. The authors concluded that Nissen–Rossetti fundoplication improves the quality of life of patients in the long-term period, with the exception of a minority of patients reporting severe persistent dysphagia (8 in this series).²⁰

Even long-term studies confirm the positive effects of surgical treatment on quality of life.^21,22

Kornmo and Ruud²¹ have used a Visick grading scale administered to 33 patients at 5 and 10 years after surgery. At 5 years the satisfaction with the intervention has proven to be very good or good in 93% of cases, and at 10 years it is further improved with 97% of patients satisfied with it. Therefore, the authors came to the conclusion that laparoscopic antireflux surgery provides good long-term results.²¹

Dallemagne et al.²² considered 100 patients who underwent laparoscopic antireflux surgery and compared the data obtained after administration of a standardized symptom questionnaire at 5 and 10 years after surgery; at 10 years a questionnaire on quality of life (GIQLI) was added. Five years after the operation, 93% of patients were asymptomatic and at 10 years 89.5%; GIQLI score at 10 years was 113.5±20.75. From the data obtained, they concluded that the control of symptoms related to GERD improves quality of life and reduces the need to take PPIs daily, results that are confirmed at 5 and 10 years after surgery.²²

In this study we obtained similar results that confirm what has already been seen in previous works. Preoperative GERD-HRQL average was 23.04 (SD±11.59), it decreased to 9.84 (SD±8.98) at 6 months, to 8.34 (SD±8.98) at 12 months and it was 6.8 (SD±6.46) and at 24 months. In addition, all fields considered in the SF-36 have improved considerably over the follow up controls, in particular the domains related to physical and general health.

Studies that include functional data are less numerous, but the 24-hour pH monitoring is essential for a correct diagnosis of GERD, and it can provide objective and sensitive information on the possible reflux recurrence after surgery, even in asymptomatic patients.

Actually, Khajainchee et al.²³ have shown that even after the surgery and despite the absence of symptoms, 12% of patients had an increased level of acid exposure, whereas 20% of patients who were symptomatic had negative pH-metry. This showed the importance of including this type of investigation in the diagnosis and follow-up of GERD.²³

Vidal et al.²⁴ carried out a study involving 130 patients who underwent laparoscopic Nissen–Rossetti fundoplication. Patients were evaluated preoperatively with symptom questionnaires, upper endoscopy, a barium swallow esophagogram, and functional tests including manometry and 24-hour pH monitoring. The results obtained showed that there was a significant reduction in symptoms; 90% of patients were asymptomatic at the last evaluation carried out. Lower esophageal sphincter pressure increased from preoperative values of 12.1±1 mm Hg to 17.8±1 mm Hg, whereas the percentage of total acid exposure decreased from 9.4±1% to 0.7±1%. Recurrences occurred in 17 patients including 8 symptomatic cases: 5 of these patients had a positive pH-metry, and esophagitis was found in the endoscopic control, while in 3 cases a defective wrap was detected at radiological control. Finally, 4 asymptomatic patients had increased pH-metry values. The authors came to the conclusion that in selected patients, control of reflux can be obtained after surgery in 90% of cases. In addition, stressing the idea expressed by many other authors, this study confirmed that 24-hour pH monitoring is essential to demonstrate the presence of reflux when there is no radiological or endoscopic evidence of defective wrap.²⁴

In agreement with the results obtained by other authors, in this series there has been a functional improvement evaluated by 24-hour pH monitoring. The advantage of this study was a more rigorous and standardized follow-up that has allowed a more accurate monitoring of patients over time. The DeMeester and Johnson score average decreased from a preoperative value of 35.48 (SD±40.24) to 9.83 (SD±6.40) at 6 months, 11.44 (SD±10.28) at 12 months, and 10.25 (SD±5.61) at 24 months.

In the period under consideration 1 case of recurrence was observed; endoscopy follow-up, pH-metric evaluation, and barium swallow were positive for recurrent GERD, and reoperation was required.

From the results obtained we can conclude that laparoscopic Nissen–Rossetti fundoplication creates an effective barrier to both acid and bile reflux; 24-hour pH monitoring is important for the functional evaluation after surgery, and it is a sensitive test for the detection of recurrence even in asymptomatic patients.

Conclusions

Laparoscopic Nissen–Rossetti fundoplication is effective in GERD treatment and provides better reflux control when compared with medical therapy, which controls acid reflux only. Moreover, as shown in the short- and medium-term results reported in this study, antireflux surgery improves quality of life and reduces the exposure of the distal esophagus to acid and bile, recreating a barrier for any type of reflux.

The control of reflux is essential in preventing progression of disease, and it is backed up by the fact that, in most studies, patients with progression after surgical treatment seem to have recurrent reflux.

In this regard, we want to stress the importance of a rigorous follow-up with both subjective and objective tests in patients undergoing antireflux surgery in order to identify asymptomatic recurrence of reflux, which increases the risk of disease progression.

Footnotes

Disclosure Statement

No competing financial interests exist.

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